The Golden Rules of Hosting an Audit

In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry.

Who’s Àngels Llarch?

Currently working as API Compliance Head/Deputy RP at IMCD Switzerland AG, Àngels has more than two decades of solid experience, working in the Quality domain for several renowned pharmaceutical suppliers. She loves audits as they serve as a tool to discover new ways of implementing good manufacturing practices across the industry.

In This Blog Post, You Will Learn:

• What is an audit, and why is it performed?
• Do audits lead to the opening of pandora’s boxes?
• How to prepare for an external audit
• Golden rules for hosting external audits by Àngels Llarch
• How to build trust with your auditor

What Is An Audit – And Why Is It Performed?

Audits are on-the-scene inspections of processes, quality systems, or finances of a company by an independent entity. This is done to ensure conformity between the set standards of a process and how it is being carried out in the organization under inspection. Simply put, an auditor examines whether a company is fulfilling necessary requirements and following set guidelines or not. Purposes of external audits include:

• Verification of procedures, materials, or finances in a company
• Attaining transparency and accountability
• Ensuring that the company follows standard guidelines
• Identification of problems and malpractices
• Obtaining an unbiased review from a third party

Do Audits Lead To Opening Of Pandora’s Boxes?

Although being a tool for improvement and learning, audits can actually lead to the opening of pandora’s boxes too. But this depends upon certain factors. For example, if your company’s quality management is compromised, then yes, audits will lead to the discovery. However, there are other things to consider as well. Sometimes making minor mistakes such as spontaneously or deliberately “inventing” things upon a sudden inquiry by the auditor can lead to a chain of uncovering questions, ultimately landing you in trouble. That happens when you fail to build trust with your auditor and replace it with doubts instead—implanting doubts, whether consciously or involuntarily, should be avoided. However, looking as a whole, audits primarily serve as great opportunities instead. Actually, that is the case most of the time. Why audits sound scary to many companies has its roots in our psychological inclination towards examinations. Exams sound scary and seem like they’re going to be troublesome. But without them, we cannot prove ourselves. Audits are similar. They open the doors to finding new ways of betterment and opportunities.

Àngels Llarch’s Golden Rules – For Hosting An Audit:

Àngels share valuable tips regarding hosting audits in our podcast. We’re summarizing it here.

1.     Make Your Preparations In Time:

Before the day arrives- prepare for it!

• Compile all the information beforehand to have quick and easy access to anything you may need during the audit.
• Recheck everything before entering the site. Look for possible mistakes, missing documents, or missing signatures.
• Ensure all your departments and all the personnel available on the auditing scene are on the same page. Practicing before the audit day might be a good idea.
• It is of great value to know your auditor. Auditors can be a third party, a regulatory body, or even your customers. Host them keeping in mind their interests. For example, a private third party sent on a contract is more likely to pick nitty-gritty details than a customer who is merely interested in observing and questioning production processes.

2.     Two Rules To Keep In Mind During The Audit:

These two rules go along with each other in succession, one following the other:

1. Answer the inspector or the auditor only upon request.
2. Answer only what the auditor requested from you.

During the inspection process, you are not supposed to describe everything that is happening at the scene. Things are right there in front of the auditor, and it is their job to inspect and question if needed. Many people make the mistake of speaking along unnecessarily during the audit. This is what creates a chance of opening the pandora’s boxes. Provide the auditor with an untroubled working environment. Only when they request you an answer, you have to speak. That is rule number one. If they don’t ask, don’t tell. And when they ask, only tell about what they ask. Try not to go an inch beyond. That is rule number two.

3.     Build Trust With Your Auditor:

Building your credibility in the eyes of your external auditor is hands down the most precious achievement. That’s what Àngels Llarch says about trust in our podcast: “It takes a lot to build it up, and it’s very easy to knock it down.” How to build trust is a matter of being honest. Transparency and professional truthfulness are the keys to trust-building. There are many things in this regard that you can practically do. For example:

• There will be problems in your company that you’d be aware of. Start or end the meeting by informing the auditor that these are the issues, we are fully aware of them, and we are working on them.
• Clarify any contradictions that arise during the meeting or the audit in the end, most politely and honestly.
• You can present the annual quality review from last year. Inform the auditor about what corrections your company successfully made, what problems still exist, and how you are dealing with them.

This way, becoming a facilitator of your auditor will help you a lot by building trust and confidence. Create ease for them and things will be easy for you as well.

4.     Utilize Internal Audits – Agreement And Prioritization:

Internal audits are a great tool to assess your company’s quality, performance, capabilities, and GMP compliance. If done right, they can constantly provide practical ideas for improvement in different work areas. Yan and Àngels talk about how departments give each other “medals” of highness after performing internal audits. This is a kind of the wrong approach. Internal audits are not meant solely for medals of appreciation. Instead, departments should be dedicated to improving each other. That is done by identifying potential problems through internal audits. However, making this list of problems is not the end step. And unfortunately, that is what many companies do. They make a list of problems and put them under the drawer. What you have to do instead, is to prioritize your observations and issues, make an agreement upon the observations between departments, and then opt for corrective actions. Prioritization increases efficiency by maintaining focus on one big problem at a time. Implementing corrective actions becomes much easier and effective using this method.

Instil Quality In Every Department:

As Àngels says, the quality department should not be the only one that focuses on quality. After all, quality assurance and quality control cover the whole company. You must undertake active efforts to inculcate quality culture in every department, right down to every individual. That develops a capability in your company to ace any audit. And secondly, you have to do this during an audit as well. Involve as many departments as you can, not just the quality departments. This portrays coherence and outstanding communication among your departments, and it is likely to please the auditor. Representation from every department in an audit displays professionalism, as you are presenting your whole production team for crystal clear accountability, testing, and quality check.

Dealing With High-Risk Scenarios:

Certain situations may be met during an audit where revealing, skipping, or stumbling at something might land you in trouble. Broadly this can be dealt with using two strategies.

1. The first one is hiding. While deliberately faking or not revealing the truth may allow you to pass sometimes, but this is a flawed approach. Hiding shifts you to an even higher risk situation where the slightest imbalance will bring harsher consequences for you. It will break trust and promote dishonesty. So, go for the second option and remove this one from your inventory.
2. Be transparent- it is the only option. Identifying problems and allowing you to improve is the very purpose of auditing. Do not compromise trust-building and honesty for a temporary sigh of relief. Adhering to the truth will take you out of the risk.

The Always-Ready Attitude:

Audits don’t happen all the time. Well, if you suppose that audits are happening all the time and fine-tune your organization to be always ready for one. What about that? This makes for a great approach towards dealing with audits and improving your quality altogether. In your day-to-day routine, adopt certain habits that an otherwise scary audit might not bother you. Always be audit-ready, and you’ll don’t have to worry about an audit ever again. Sounds great and is applicable too. But you have to work a little hard for this in the beginning. Inculcate this culture down to every individual of your organization and train them to be audit-ready. After a slight steep rise, the difficulty graph for your company will become flat, and things will become much more manageable.

Conclusion:

Contrary to the common perception, audits are primarily a tool for improvement and not something to be worried about. This largely depends on how you deal with them. Àngels’s useful tips backed by her two decades of experience will be your premium guide in this regard. Learn the purpose of auditing, the importance of Good Manufacturing Practices, train your staff on these philosophies, and audits will never be a problem for you.